SpiroWay

GUDID 04057155000818

Mouthpiece, accessory to spirometer

eResearchTechnology GmbH

Diagnostic spirometer, professional

• Primary Device ID: 04057155000818
• NIH Device Record Key: 6c56197d-27b7-440f-9bc7-8a07bfaac15a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiroWay
• Version Model Number: SpiroWay
• Company DUNS: 341625331
• Company Name: eResearchTechnology GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com
• Phone: +1 908 595 2020
• Email: customercare@clario.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000801 [Primary]
GS1	04057155000818 [Package]; Contains: 04057155000801; Package: box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213754

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-30
• Device Publish Date: 2024-07-22

Devices Manufactured by eResearchTechnology GmbH

• 04057155000580 - SpiroSphere: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
• 04057155000597 - SpiroSphere: 2024-07-30 Diagnostic device for ECG measurement and data collection
• 04057155000665 - SpiroSphere: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
• 04057155000672 - SpiroSphere: 2024-07-30 Diagnostic device for ECG measurement and data collection
• 04057155000689 - SpiroSphere: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
• 04057155000696 - SpiroSphere: 2024-07-30 Diagnostic device for ECG measurement and data collection
• 04057155000795 - iSpiro Ultrasonic Sensor: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters.
• 04057155000818 - SpiroWay: 2024-07-30Mouthpiece, accessory to spirometer
• 04057155000818 - SpiroWay: 2024-07-30 Mouthpiece, accessory to spirometer